MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)— 510(k) K982277

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K982277 for MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991), Substantially Equivalent on 1998-07-22. Applicant: Nova Biomedical Corp..

Clearance details

Applicant: Nova Biomedical Corp.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1998-06-29
Decision date: 1998-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

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Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.